Laropiprant Clinical Trials

Size	Price	Qty
5mg	USD 179
25mg	USD 537

Clinical Trials

Several clinical trials have evaluated laropiprant primarily for cardiovascular and lipid-related metabolic disorders, including hypercholesterolemia, dyslipidemias, and coronary heart disease, across Phase I, Phase III, and Phase IV investigations. Sponsored by pharmaceutical entities such as Merck Sharp & Dohme LLC as well as academic institutions like University Medical Centre Ljubljana and Hospital Miguel Servet, these studies evaluated the safety, pharmacokinetics, and lipid-modifying efficacy of laropiprant combinations. Recruitment statuses across these studies vary, with recorded trials listed as completed, terminated, or withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01583647	Terminated	Hypercholesterolemia Familial\|Heterozygous Familial Hypercholesterolemia	Merck Sharp & Dohme LLC	2012-06	Phase 1
NCT01308203	Terminated	Coronary Artery Disease\|Dyslipidemias	Daniel A. Siniawski\|Merck Sharp & Dohme LLC\|Hospital Italiano de Buenos Aires	2011-10	Phase 4
NCT01321034	Completed	Hypercholesterolemia	Instituto Aragones de Ciencias de la Salud\|Hospital Miguel Servet	2011-10	Phase 4
NCT01126073	Completed	Coronary Heart Disease	University Medical Centre Ljubljana	2010-09	Phase 4
NCT00664287	Withdrawn	Dyslipidemia	Merck Sharp & Dohme LLC	2008-09	Phase 3

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Laropiprant product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Laropiprant functions as a potent and selective antagonist of the prostaglandin D2 receptor with a Ki value of 0.57 nM, competing with endogenous prostaglandin D2 to block downstream G protein-coupled receptor signal transduction. By inhibiting receptor activation, laropiprant suppresses intracellular signaling pathways that induce cutaneous vasodilation, providing clinical utility in managing lipid disorders such as hypercholesterolemia, dyslipidemia, and coronary artery disease.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).